A study of 3 doses of Progenta versus placebo versus Lucron Depot for treatment of leiomyomata.
Three doses of Progenta (CDB4124 - 12.5, 25, 50 mg) versus placebo versus Lucron Depot (leuprolide acetate for depot suspension) was initiated in females with symptomatic leiomyomata. A single dose PK visit was conducted only for subjects randomized to the Progenta arm, between screening and visit 1. A second PK assessment was conducted at Visit 3 (one month on drug) to collect steady state data. Treatment period lasted for 3 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
29
Medical University /MTZ Clinical Research Sp.zo.o.
Warsaw, Poland
Assess the safety of Progenta when administered in pre-menopausal women with symptomatic leiomyomata.
Time frame: 90 days
Determine the tolerability of three doses of Progenta (12.5 mg, 25 mg, and 50 mg) as compared to placebo and Lucron Depot (leuprolide acetate for depot suspension) in pre-menopausal women with symptomatic leiomyomata.
Time frame: 90 days
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3.75 mg IM monthly
Administered as a once daily oral dose for 90 days.